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Идёт набор NCT06471816

Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens

Без фазы С лечением Child Behavior Child Development

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dialogue Based Early Detection, Traditional parent-teacher meeting.
Кому может быть актуально
Состояния в реестре: Child Behavior, Child Development. Базовые параметры: 2 лет — 3 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if the novel Dialogue Based Early Detection (DBED) method can prevent impaired mental health in kindergarten children. It will also learn about the screening properties of DBED to identify children with impaired mental health, if DBED facilitates early interventions, and if DBED is well accepted and sustainable in an ordinary kindergarten setting. The main questions it aims to answer are: * Do children in kindergartens where DBED is implemented develop better mental health scores than children in kindergarten where DBED is not implemented? * How well identifies DBED kindergarten children with impaired mental health compared to a traditional screening instrument (the Strengths and Difficulties Questionnaire)? * What is the impact of DBED on activation of interventions for mental health problems? * What is the social validity of DBED? Researchers will compare outcomes in kindergartens where DBED is implemented with outcomes in kindergartens where it's not. * During the last three years of kindergarten attendance participants (parents of kindergarten children) in the intervention kindergartens will take part in the biannual DBED parent-teacher meetings, while participants in the control kindergartens will take part in traditional parent-teacher meetings. * Twice a year all participants will answer questionnaires of the child's mental health and parental stress during the follow-up period (3 years in kindergarten and 2 first years in school). * Participants in the intervention kindergartens will answer user satisfaction questionnaires after every parent-teacher meeting. * The kindergarten teachers will report on type and time of supportive interventions for each participating child during the follow-up period in kindergarten.

Вмешательства

  • Другое Dialogue Based Early Detection
    Before the biannual parent-teacher meeting, both the kindergarten teacher and the parents will complete the Early Worry Questionnaire containing 39 items related to development and well-being of the individual child. For each item the respondents are asked to indicate if they during the last three months have been concerned. In the parent-teacher meeting they will discuss their possible concerns and try to reach an agreement on how to evaluate the child. If necessary, possible supportive interve
  • Другое Traditional parent-teacher meeting
    This is an annual or biannual meeting that is prepared by the kindergarten teacher where (s)he reports on the child's appearance / behaviour and possible challenges as to development and behaviour from an educationalist's view. There are no common templates for the agenda of such meetings, however, usually the kindergarten teacher's perspective and opinion will dominate.

Первичные конечные точки

  • Total difficulties score of the Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: [Time Frame: The SDQ is completed by both kindergarten teacher and each parent twice a year with approximately 6 months intervals during the three last year of attendance of the child in kindergarten, continued by the parents during the first two years i]

Критерии участия

Критерии включения

  • Attendance in kindergarten
  • Inclusion during the first half-year of the third last year in kindergarten

Критерии исключения

  • Parents don't communicate in Norwegian or English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Норвегия · 3 центра
  • Haukeland University Hospital — Bergen
  • Eventus Barnehage AS — Bergen
  • Øygarden municipality — Straume

Публикации

  • Bjelland I, Wergeland GJ, Gillberg C, Gjestad R, Visnjic-Jevtic A, Lisaeth VK, Miniscalco C, Tufta ALF, Vermeer IL, Sadownik AR, Wilson P, Posserud MB. PRO-DIALOG-the effect of a novel dialogue-based parent-teacher conference on mental health in kindergarten children: a cluster randomized controlled trial. Trials. 2025 Aug 21;26(1):299. doi: 10.1186/s13063-025-08980-x. PMID 40842037

Идентификаторы

NCT: NCT06471816 · 151749

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗